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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01234662
Other study ID # CESAR
Secondary ID
Status Active, not recruiting
Phase N/A
First received November 3, 2010
Last updated May 31, 2012
Start date November 2010
Est. completion date December 2012

Study information

Verified date May 2012
Source Charite University, Berlin, Germany
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Interventional

Clinical Trial Summary

To compare three Types of anesthetic techniques (Spinal anesthesia, Combined spinal epidural anesthesia, Combined spinal epidural anesthesia with indwelling catheter for 24 hrs) on pain after elective cesarean section.


Description:

Regional analgesia is the most effective way of providing analgesia during labor and delivery. By using a combination of local anesthetics and opioids, it is often possible to avoid motor block. Spinal anesthesia is suitable for most elective cesarean sections. Epidural anesthesia and in particular catheter based epidural anesthesia allow a gradual extension of anesthesia and are suitable for prolonged treatment of postoperative pain.

It is unclear which anesthetic technique provides better pain relief after cesarean section.

This prospective, randomized study compares the effectiveness of three types of regional anesthetic techniques (Spinal anesthesia, Combined spinal epidural anesthesia, Combined spinal epidural anesthesia with indwelling catheter for 24 hrs) on pain after elective cesarean section.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 171
Est. completion date December 2012
Est. primary completion date April 2012
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Female patients aged greater than or equal to 18 years

- Patients without severe illnesses (American Society of Anaesthesiologists [ASA] grade II-III)

- Patients for elective cesarean sections

- Informing patients about risks and complications of anesthesia until 24 hrs before operation

Exclusion Criteria:

- Lacking willingness to regional procedures

- No offered patient information and written informed consent

- Persons without the capacity to consent

- Unability of German language use

- Preterm delivery < 28 weeks of pregnancy

- Chronic pain or chronic analgesic intake in medical history

- Alcohol, dope and medication abuse

- Psychiatric disease in medical history

- Baby death after delivery

- Anxiolytic medication

- Allergy to local anaesthetics

- History of bleeding tendency

- Eclampsia and HELLP syndrome

- Elective section out work routine time

- Participation in another clinical trial during the trial, one month before screening and three months after screening

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
SPA
Spinal anesthesia and opioids
CSE
CSE and epidural opioids
CSEPCEA
CSE and continuous epidural patient controlled analgesia using an epidural catheter for 24 hrs

Locations

Country Name City State
Germany Department of Anesthesiology and Intensive Care Medicine, Campus Virchow Klinikum, Campus Charité Mitte, Charite University, Berlin Berlin

Sponsors (1)

Lead Sponsor Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Postoperative pain levels during movement (cough) Patient self-assessed postoperative pain levels during movement (cough) using an unmarked zero to one hundred mm visual analog scale (VAS) At nine hours after the end of surgery (closure time) Yes
Secondary Postoperative pain levels during rest Patient self-assessed postoperative pain levels during rest using an unmarked zero to one hundred mm visual analog scale (VAS) At nine hours after the end of surgery (closure time) Yes
Secondary Postoperative pain levels during rest and movement Patient self-assessed postoperative pain levels during rest and movement using an unmarked zero to one hundred mm visual analog scale (VAS) At zero (injection), one, two, six, nine, twenty four, fourty eight hours after the end of surgery (closure time) Yes
Secondary Change of type of anesthesia when regional anesthesia fails During the operation Yes
Secondary Level of anesthesia during the operation During the operation Yes
Secondary Incidence of hypotensions during the operation During the operation Yes
Secondary Sedation level (Ramsay-Score) Postoperative course Yes
Secondary Capability for mobilisation and time to first mobilisation Postoperative course Yes
Secondary Incidence of adverse reactions (PONV, headache and backpain, urinary retention) Postoperative course Yes
Secondary Satisfaction with pain management Postoperative course No
Secondary Co-analgesics Co-analgesic consumption In the 48-hour postoperative sample period Yes
See also
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Completed NCT03853694 - Efficacy and Safety of EXPAREL Versus Standard of Care (SoC) in Subjects Undergoing Elective Cesarean Section Phase 4
Completed NCT01248078 - Antibiotic Prophylaxis Before Surgery Versus After Cord Clamping in Elective Cesarean Delivery - a Double-blind, Prospective, Randomized Placebo-controlled Trial N/A
Recruiting NCT05236985 - Oxytocin Bolus Versus Infusion in Elective Cesarean Section" Phase 4
Completed NCT01862432 - Immediate Skin-to-skin Contact After C-section N/A
Completed NCT04370847 - Ultrasonography for Fluid Assessment in Parturients With Preeclampsia Undergoing Cesarean Section
Recruiting NCT06155968 - Evaluating The Quality of Recovery After Elective Cesarean Section N/A
Completed NCT03549884 - Delayed Cord Clamping in Infants Born by Cesarean Section N/A
Completed NCT03507387 - Preventive Intramuscular Phenylephrine in Elective Cesarean Section Under Spinal Anesthesia N/A